Each kit contains:
(A) One efavirenz tablet
Each film-coated tablet contains:
Efavirenz ……… 600 mg

(B) Two lamivudine and zidovudine fixed-dose combination tablets
Each film-coated tablet contains:
Lamivudine ………. 150 mg
Zidovudine ……….. 300 mg

DUOVIR-E Kit is indicated for the treatment of HIV infection in adults.

Adults
Morning
One white tablet (zidovudine 300 mg and lamivudine 150 mg) to be taken in the morning.

Evening
One white tablet (zidovudine 300 mg and lamivudine 150 mg) and one yellow tablet (efavirenz 600 mg) to be taken in the evening. It is recommended that the yellow tablet (efavirenz) be taken on an empty stomach, preferably at bedtime. Bedtime dosing improves the tolerability of nervous system side effects.

Dosage Adjustment
A reduction in the daily dose of zidovudine may be necessary in patients with mild to moderate impaired hepatic function or liver cirrhosis. Hence, DUOVIR-E Kit is not recommended for patients with impaired renal function.

DUOVIR-E Kit should also not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance <50 mL/min) or those experiencing dose-limiting adverse events.

DUOVIR-E Kit is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the kit.

Hypersensitivity
Efavirenz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.

Contraindicated Drugs
For some drugs, competition for CYP3A by efavirenz could result in inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions (eg, cardiac arrhythmias, prolonged sedation, or respiratory depression). Drugs that are contraindicated with efavirenz are listed in Table 2.

Table 2: Drugs That Are Contraindicated or Not Recommended for Use with Efavirenz

DUOVIR-E Kit ...................Carton containing 10 kits